Cleared Special

K061352 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY

K061352 is an FDA 510(k) clearance for PERI-LOC PERIARTICULAR LOCKED PLATING S..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 24-day FDA review.

K061352 · Smith & Nephew, Inc. · Orthopedic device
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Jun 2006
Decision
24d
Days
Class 2
Risk

K061352 is an FDA 510(k) clearance for the PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on June 8, 2006 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K061352

510(k) Number K061352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2006
Decision Date June 08, 2006
Days to Decision 24 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1224
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K061352.
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
K053624 · Medicon EG · Jul 2006
CALCANEAL TRAUMA SYSTEM
K061400 · Orthohelix Surgical Designs, Inc. · Jun 2006
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
K061211 · Zimmer GmbH · Jun 2006
LORENZ PECTUS SUPPORT BAR, TITANIUM
K061384 · Walter Lorenz Surgical, Inc. · Jun 2006
EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
K061098 · Ebi, L.P. · May 2006
AXSOS PLUS LOCKING PLATE SYSTEM
K061012 · Howmedica Osteonics Corp. · May 2006